Absorbable Sutures in Vascular Surgery

Summary

Absorbable sutures are not generally accepted by the majority of vascular surgeons for the
possible complications such as the breakage of the suture at the anastomoses level. Some
experimental and clinical studies in the current literature demonstrated that the use of
absorbable sutures may even reduce some important complications such as restenosis.

The aim of this study is to compare absorbable and non-absorbable sutures in patients
undergoing peripheral vascularsurgery with vein bypass grafting.

Description

Infrainguinal vein graft procedures may be performed, generally, on patients with critical
limb ischemia (CLI) or popliteal artery aneurysm (PAA). Autologous vein graft, when adequate
and available, is usually the preferred conduit, especially in the below knee vascular
districts. Vein grafts may complicate with the onset of stenoses (up to 30% of cases). Such
complications may develop, due to myointimal hyperplasia along the body of the graft or,
more often, at the proximal or distal anastomoses where sutures are performed. In vascular
surgery procedures, in case of arterial anastomoses, absorbable suture material is generally
not preferred, mainly for the fear of breakage of the suture line. Previous experimental
studies performed in animals and humans and a recent clinical study performed in humans on
carotid surgery showed that absorbable sutures used in vascular surgery may even reduce the
development of intimal hyperplasia and may reduce postoperative stenotic complications. The
aim of this study is to evaluate the early and long-term results of absorbable sutures used
in peripheral vascular surgery.

This is an open-label, parallel group study.

Patients undergoing vein bass grafting for CLI or PAA may be suitable for entry into ASPeVas
trial. They must satisfy the following inclusion criteria:

Both sex. Age > 18 years old. Patients undergoing femoropopliteal or femorodistal vein
bypass grafting; must be able to give informed consent; have no significant co-morbidity
that makes life expectancy less than six months.

The randomisation process consists as follows: once a patient have consented entering the
trial, an envelop is opened and the patient is offered the type of suture (absorbable or non
absorbable) regardless of the surgical technique which is going to be performed
(femoropopliteal or femorodistal vein bypass grafting).

All patients have to be followed-up, the day after the operation (time 0) and then
subsequently at 1, 3,6,9,12 and 18 months.

At each appointment, Ankle Brachial Pressure Index (ABPI) is measured and then Duplex
scanning (DS) is performed. In particular, by means of DS the peak systolic flow velocity
(PSFV) at multiple sites along the entire graft is measured. A graft at risk of failure was
defined as having a PSFV < 45 cm/s or a ratio of V2 (peak velocity at the site of the
stenosis) to V1 (peak systolic velocity at any other point within 2 cm at the normal
adjacent graft) > 2. Any other irregularities, such as inflow/outflow problems, graft
dilatation will be also recorded.

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Medical and Biotech [MESH] Definitions

Suture Anchors

Implants used in arthroscopic surgery and other orthopedic procedures to attach soft tissue to bone. One end of a suture is tied to soft tissue and the other end to the implant. The anchors are made of a variety of materials including titanium, stainless steel, or absorbable polymers.

Polydioxanone

An absorbable suture material used also as ligating clips, as pins for internal fixation of broken bones, and as ligament reinforcement for surgically managed ligament injuries. Its promising characteristics are elasticity, complete biodegradability, and lack of side effects such as infections.

Polyglycolic Acid

A biocompatible polymer used as a surgical suture material.

Cerclage, Cervical

The surgical closure of the incompetent cervix uteri with suture material.

Suture Techniques

Techniques for securing together the edges of a wound, with loops of thread or similar materials (SUTURES).

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